RESUMO
BACKGROUND: This study was designed to evaluate the efficacy and safety of cold-adapted influenza vaccine, trivalent (CAIV-T) against culture-confirmed influenza in children 12 to <36 months of age during 2 consecutive influenza seasons at multiple sites in Asia. METHODS: In year 1, 3174 children 12 to <36 months of age were randomized to receive 2 doses of CAIV-T (n = 1900) or placebo (n = 1274) intranasally > or =28 days apart. In year 2, 2947 subjects were rerandomized to receive 1 dose of CAIV-T or placebo. RESULTS: Mean age at enrollment was 23.5 +/- 7.4 months. In year 1, efficacy of CAIV-T compared with placebo was 72.9% [95% confidence interval (CI): 62.8-80.5%] against antigenically similar influenza subtypes, and 70.1% (95% CI: 60.9-77.3%) against any strain. In year 2, revaccination with CAIV-T demonstrated significant efficacy against antigenically similar (84.3%; 95% CI: 70.1-92.4%) and any (64.2%; 95% CI: 44.2-77.3%) influenza strains. In year 1, fever, runny nose/nasal congestion, decreased activity and appetite, and use of fever medication were more frequent with CAIV-T after dose 1. Runny nose/nasal congestion after dose 2 (year 1) and dose 3 (year 2) and use of fever medication after dose 3 (year 2) were the only other events reported significantly more frequently in CAIV-T recipients. CONCLUSIONS: CAIV-T was well tolerated and effective in preventing culture-confirmed influenza illness over multiple and complex influenza seasons in young children in Asia.
Assuntos
Adaptação Fisiológica , Temperatura Baixa , Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/imunologia , Influenza Humana/prevenção & controle , Orthomyxoviridae/imunologia , Vacinas Atenuadas/imunologia , Ásia/epidemiologia , Pré-Escolar , Método Duplo-Cego , Feminino , Humanos , Lactente , Influenza Humana/diagnóstico , Influenza Humana/epidemiologia , Masculino , Orthomyxoviridae/fisiologia , Vacinas Atenuadas/efeitos adversosRESUMO
We report 72 patients with Kawasaki disease seen at this Centre over 7 years. Cardiac involvement in the form of mild pancarditis was seen in 28 % patients, but disappeared subsequently. Thirteen (18.5 percent) children developed coronary artery disease, out of which 4 resolved by the end of two months and another 6 after one year; 3 patients continued to show coronary artery dilatation and aneurysm formation. Children who received IV gammaglobulin in full dose within 10 days of onset of illness, showed no evidence of coronary artery disease during follow up.